An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma

Trial Information

An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma

OBJECTIVES: I. Determine the maximum tolerated dose of taurolidine in patients with
recurrent or progressive high-grade glioma. II. Determine the safety and toxicity of this
drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
IV. Determine the response in patients treated with this drug.

OUTLINE: This is a dose-escalation study. Patients receive taurolidine IV over 1-4 hours on
days 1-5, 8-12, and 15-19. Treatment repeats every 6 weeks in the absence of disease
progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of
taurolidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for this study.

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life
expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL
AST/ALT less than 3 times upper limit of normal No indication of acute hepatitis or
parenchymal liver disease No significant hepatic disease that would preclude study Renal:
Creatinine less than 1.7 mg/dL No significant renal disease that would preclude study
Cardiovascular: No significant cardiac disease that would preclude study Other: HIV
negative No other active malignancy except curatively treated carcinoma in situ of the
cervix or basal cell skin cancer No significant psychiatric disease that would preclude
study No significant gastrointestinal disease that would preclude study No known
hypersensitivity to taurolidine or its excipients Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

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